Implant system and method for bulking tissue

ABSTRACT

A system for placing an implant in the body includes an elongated member having at least one inner lumen extending from a proximal end portion of the member to an opening in a distal end portion of the member. At least one compressible implant is in the inner lumen of the member. The implant optionally includes anchor members projecting from its outer surface to limit migration of the implant in the body. Structure is provided to push the implant through the opening in the distal end of the member. The implant is placed between layers of body tissue to bulk the tissue. In one of the disclosed methods, the system is used to treat gastroesophageal reflux disease (GERD) by placing the implant between layers of body tissue at or near the gastroesophageal junction.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to an implant and a system and method forplacing the implant in the body to bulk body tissue. More particularly,the present invention relates to a system and method for placing theimplant at or near the gastro-esophageal junction to treatgastroesophageal reflux disease (GERD).

2. Description of Related Art

The lower esophageal sphincter is located in a distal portion of theesophagus adjacent to the junction between the esophagus and thestomach. When food is digested, a properly functioning lower esophagealsphincter allows food to pass from the esophagus to the stomach whilelimiting reverse flow of the stomach contents into the esophagus.

Gastroesophageal reflux disease (GERD) is a disorder in which the loweresophageal sphincter allows contents of the stomach including gastricacid and bile to reverse flow into the distal portion of the esophagus.Complications associated with GERD include heartburn, pulmonarydisorders, chest pain, esophageal ulcers, esophagitis, Barrett'sesophagus, and esophageal carcinoma.

A common treatment for GERD includes administering prescription acidblockers for limiting gastric production of acid. Although these drugsmay provide short term relief, the drugs merely alleviate some of thesymptoms of GERD rather than correcting the underlying dysfunction ofthe lower esophageal sphincter. In addition, acid blockers areexpensive, and any long term complications associated with using acidblockers are unknown.

Various surgical procedures have been attempted to correct GERD. In onesurgical procedure, known as Nissen fundoplication, a portion of thegastric fundus is wrapped around the esophagus. The wrapped gastricfundus applies pressure to the esophagus to limit reverse flow of thestomach contents into the esophagus. Conventional fundoplicationprocedures are effective at treating GERD, but they have a number ofdisadvantages. Open procedures require a large incision to expose thestomach and the lower esophagus. In laparoscopic procedures, four orfive smaller incisions are formed in the abdominal wall to insertinstruments into the body of the patient. However, such procedures areexpensive and sometimes require a significant amount of time for patientrecovery.

Some other procedures, such as those disclosed in U.S. Pat. No.5,403,326 and in U.S. Pat. No. 5,571,116, use surgical staples to securethe fundus of the stomach and the lower esophagus. However, some of therelatively rigid stapling instruments used in these procedures maydamage tissue when they are moved in a patient. In addition, such rigidinstruments are inserted into the operative field with trocar typedevices which make abdominal wall penetrations. These abdominal wallpenetrations increase the risks of post-operative hernias, accidentalorgan perforations, or other drawbacks associated with laparoscopicsurgery.

Bulking the tissue of the digestive track at or below thegastro-esophageal junction is a relatively recent, investigativetreatment for GERD. In one such treatment, collagen in a saline carrieris placed in the tissue around the gastro-esophageal junction to causepartial closure of the distal end of the esophagus and thereby preventgastric acid from reaching the esophageal mucosa. Although the collagencould provide short term benefits, it eventually becomes absorbed by thebody and loses it effectiveness.

Bulking of body tissue is also performed in a number of other treatmentsand procedures. For example, tissue is bulked in cosmetic surgicalprocedures and in treatments for urinary incontinence. However, thecurrent implants and devices for inserting them have a number ofdisadvantages when they are used for tissue bulking.

In light of the foregoing, there is a need in the art for an improvedimplant, implantation system, and tissue bulking procedure.

SUMMARY OF THE INVENTION

Accordingly, the present invention is directed to an implant, system andmethod that substantially obviate one or more of the limitations of therelated art. To achieve these and other advantages and in accordancewith the purpose of the invention, as embodied and broadly describedherein, the invention includes a system for placing an implant in thebody. The system comprises an elongated member and at least onecompressible implant in an inner lumen of the member. The implant isconfigured to be implanted in body tissue to bulk the tissue. Structureis provided for pushing the implant through an opening in a distal endportion of the member.

In an aspect of the invention, the structure for pushing the implantincludes a pushing member movable in the inner lumen or a source offluid for pressurizing the inner lumen.

In another aspect, the elongated member has a first lumen for theimplant and a second lumen for passing fluid into the body to separatetissue layers.

In still another aspect, the implant includes structure for limitingmigration of the implant in the body.

In a further aspect, the present invention includes a method of bulkingtissue. In this method, the elongated member is introduced in the body.The distal end portion of the elongated member is positioned betweenlayers of body tissue. A pushing force is applied to the implant to movethe implant through the opening in the distal end portion and betweenthe layers of body tissue.

In yet another aspect, the method includes placing fluid between thelayers of body tissue to separate the layers of body tissue.

In an even further aspect, a plurality of compressible implants are inthe inner lumen of the elongated member, and more than one of thecompressible implants are placed between the layers of tissue.

In one other aspect, the implant is placed between body tissue layers ator near the gastro-esophageal junction to treat GERD.

In an additional aspect, the present invention includes an implantformed of compressible material. Anchor members project from the outersurface of the implant. The anchor members are configured tointerconnect with anchor members on another implant implanted in thebody.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary, and are intended toprovide further explanation of the invention as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of the invention and are incorporated in and constitute apart of this specification. The drawings illustrate embodiments of theinvention and, together with the description, serve to explain theprinciples of the invention. In the drawings,

FIG. 1 is partial cross sectional view of an implant placement systemaccording to a first embodiment of the invention;

FIG. 2 is a view similar to that of FIG. 1 with an implant of the systempartially pushed through a distal end opening of an elongated membershown in FIG. 1;

FIG. 3 is a perspective view of one of the implants shown in FIGS. 1 and2;

FIG. 4 is a partial cross sectional view of a second embodiment of theimplant placement system;

FIG. 5A is a cross sectional view taken along line 5-5 of FIG. 4;

FIG. 5B is a cross sectional view similar to that of FIG. 5A showing analternative lumen configuration for an elongated member shown in FIG. 4;

FIG. 6 is a schematic view showing placement of implants in thegastro-esophageal junction during a GERD treatment procedure accordingto the invention;

FIG. 7 is a schematic cross sectional view taken along line 7-7 of FIG.6;

FIG. 8 is a schematic view similar to FIG. 6 showing the implantplacement without fluid for separating tissue layers;

FIG. 9 is a schematic view similar to FIG. 7 showing an alternative GERDtreatment procedure wherein implants are substantially parallel to thelongitudinal axis of the esophagus;

FIG. 10 is a schematic cross sectional view taken along line 10-10 ofFIG. 9;

FIG. 11 is a view similar to FIG. 1 showing an embodiment of a curvedimplant insertion member;

FIG. 12 is a view similar to FIG. 3 showing an embodiment of the implanthaving hook-shaped anchors;

FIG. 13 is a view similar to FIG. 3 showing an embodiment of the implanthaving longitudinal ridges and grooves;

FIG. 14A is a cross-sectional view taken along line 14-14 of FIG. 13showing a first alternative ridge and groove shape for the implant ofFIG. 13;

FIG. 14B is a view similar to FIG. 14A showing a second alternativeridge and groove shape;

FIG. 14C is a view similar to FIG. 14A showing a third alternative ridgeand groove shape;

FIG. 15 is a view similar to FIG. 3 showing an embodiment of an implanthaving transverse ridges and grooves;

FIG. 16A is a partial cross-sectional view taken along line 16-16 ofFIG. 15 showing a first alternative ridge and groove shape for theimplant of FIG. 15;

FIG. 16B is a view similar to FIG. 16A showing a second alternativeridge and groove shape; and

FIG. 16C is a view similar to FIG. 16A showing a third alternative ridgeand groove shape.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Reference will now be made in detail to the present preferredembodiments of the invention, examples of which are illustrated in theaccompanying drawings. Wherever possible, the same reference numbers areused in the drawings and the description to refer to the same or likeparts, and similar reference numerals are used to refer to similarelements.

FIGS. 1 and 2 show an implant placement system 10 according to a firstembodiment of the invention. As shown in FIGS. 1 and 2, the system 10includes an elongated member 20 having an inner lumen 22, one or moreimplants 30 in the inner lumen 22, and a pushing member 40 for pushingthe implants 30 through both the lumen 22 and an opening 24 in a distalend portion of the elongated member 20.

The elongated member 20 is preferably a hollow needle, cannula, ortubular member having a sharpened distal end 26 configured to piercethough layers of body tissue so that the opening 24 can be positionedbetween the tissue layers. When the opening 24 is located in thisposition, one or more of the implants 30 are ejected from the opening 24and become implanted between the tissue layers. As described below, theelongated member 20 is preferably long enough to be passed transorallythrough the esophagus during a GERD treatment procedure to position thedistal end portion of the elongated member 20 between layers of tissueat or near the gastro-esophageal junction. To allow for such passagethrough the esophagus without significant trauma, the elongated member20 preferably has a sufficient amount of flexibility, and is optionallyprecurved or bent in a shape facilitating placement of the distal end 26at a desired location in the body. For example, FIG. 11 shows anembodiment of an elongated member 20A having a curved distal endportion.

The elongated member 20 could be formed of many different types ofmaterial, but materials, such as radiopaque materials, which are capableof being detected with conventional medical imaging equipment, arepreferred. In a preferred embodiment, the elongated member 20 includesbands or stripes of material capable of being visualized to determinehow far the elongated member 20 is inserted in the body.

The inner lumen 22 preferably extends from a proximal end 28 of theelongated member 20 to the opening 24 in the distal end 26. The crosssection of the inner lumen 22 could have many different shapes, howevera generally circular cross sectional shape is preferred. Preferably, thesurface of the inner lumen 22 is relatively smooth to allow for slidingof the implants 30 therethrough.

The pushing member 40 has an outer cross sectional size smaller than thecross sectional size of the inner lumen 22 to allow the pushing member40 to move axially in the inner lumen 22. Preferably, the pushing member40 is a cylindrical-shaped push rod having a length slightly longer thanthat of the elongated member 20. When at least one of the implants 30and the pushing member 40 are in the inner lumen 22, distal movement ofthe pushing member 40 with respect to the elongated member 40 forces theimplants 30 through the inner lumen 22 and through the distal endopening 24. To facilitate manipulating the pushing member 40 and theelongated member 20, the proximal ends, of both the pushing member 40and the elongated member 20 preferably include a respective handle (notshown).

FIG. 3 shows the preferred configuration of the implant 30. The implant30 is preferably made of a flexible, compretsible material, capable ofbeing compressed into a reduced size permitting the implant 30 to bestored in the inner lumen 22, and also permitting the implant 30 toexpand resiliently back to its original size after the implant 30 passesthrough the distal end opening 24, as shown in FIG. 2. Because theimplant 30 is capable of being compressed into a reduced size while itis in the inner lumen 22, the outer cross sectional size of theelongated member 20 is reduced as compared to insertion devices fornon-compressible implants. Preferred materials for forming the implantinclude urethane, silicone, and fluoropolymer.

Preferably, the implant 30 is formed of open cell foam and/or closedcell foam having a number of internal void areas. The use of closed cellfoam isolates antibody attack to the outer surface of the foam topreserve the foam's flexibility and compressibility. Closed cell foamalso reduces significant tissue ingrowth to maintain the flexibility ofthe implant 30. Open cell foam, on the other hand, permits tissue andcollagen growth in pores of the foam to reduce migration of the implant30 in the body.

In an alternative embodiment, the implant 30 is formed of an elastomericmaterial and has a hollow cavity filled with a fluid, such as air.Forming the implant 30 with such a material and cavity permits theimplant 30 to be placed in the inner lumen 22 and to maintain its shapeafter being implanted, in the body without the need to be inflated.

To permit imaging of the implant 30, the implant 30 preferably includesradiopaque material capable of being detected with conventional imagingequipment.

As shown in FIG. 3, the implant 30 preferably has a generallycylindrical shape with rounded ends. In another preferred embodiment(not shown), the implant 30 has a substantially spherical shape. Theimplant 30 could also be shaped in many other ways. For example, theimplant 30 could be have a polygonal shaped cross section, such as atriangular shaped cross section. When the implant 30 is cylindrical andin its expanded form, the implant 30 preferably has a length of fromabout 100 thousandths of an inch to about 250 thousandths of an inch,and a diameter of from about 50 thousandths of an inch to about 175thousandths of an inch, for example.

Preferably, the outer surface of the implant 30 includes structure forlimiting migration of the implant 30 when the implant 30 is implanted inthe body. In the embodiment of the implant 30 shown in FIG. 3, theimplant 30 includes anchor members 32 extending from the outer surfaceof the implant 30. The anchor members 32 preferably have a pointed orrounded end capable of engaging body tissue.

FIG. 12 shows an alternative embodiment of an implant 30A. The implant30A includes anchor members 32A in the form of hook-shaped projections.In addition to being configured to engage tissue, the anchor members 32Aare also configured to interconnect with corresponding hook-shapedprojection anchors 32A on one or more other implants 30A to form coupledgroups of the implants 30A. Optionally, the anchor members 32 and 32Aare formed of a bioabsorbable material capable of being absorbed in thebody after tissue growth around the implant 30, 30A is sufficient.

The implant 30 could also include other structure for limitingmigration. For example, the implant 30 preferably includes an outersurface coating for increasing the coefficient of friction of theimplant 30. In addition, the outer surface of the implant 30 preferablyincludes ridges, grooves, or other surface discontinuities to reducemigration and to increase the outer surface area to induce tissueingrowth. For example, FIG. 13 shows an embodiment of an implant 30Bhaving longitudinal ridges 60 and grooves 62, and FIG. 15 shows anembodiment of an implant 30C having transverse ridges 64 and grooves 66.As shown in FIGS. 14A, 14B, and 14C, the implant 30B shown in FIG. 13could have pointed ridges 60A, rounded ridges 60B, or relativelyflattened ridges 60C, and either relatively flattened grooves 62A, 62Cor curved grooves 62B. As shown in FIGS. 16A, 16B, and 16C, the implant30C shown in FIG. 15 could have pointed ridges 64A, rounded ridges 64B,or relatively flattened ridges 64C, and pointed grooves 66A, roundedgrooves 66B or flattened grooves 66C.

There are many different ways in which the implants 30 could becompressed into a reduced size and loaded into the elongated member 20as shown in FIG. 1. One of the simplest ways of loading the implants inthe elongated member 20 is to force the implants 30 into the inner lumen22. In another process for loading the implants 30 in the elongatedmember 20, the implants 30 are reduced in size by clamping, heatshrinking, or stretching, and then the reduced size implants arecryogenically frozen. Optionally, when the implant is formed of opencell material, a soaking agent, such as water, is added to the foammaterial to facilitate reducing the implant's size prior to cryogenicfreezing. Soon after freezing, the chilled implants are placed in theelongated member 20 so that the implants 30 are capable of expandingwhen they are warmed.

Other methods of initially reducing the size of the implants 20 andloading them in the elongated member 20 are possible. In one alternativemethod, a soaking agent is added to the implant, and the implant is heatdried while it is maintained in a reduced size. The heat drying causesthe implant to remain in its reduced size until the implant comes incontact with a liquid, such as water and expands like a conventionalkitchen sponge. In another alternative embodiment, the implant is placedin its reduced size by applying a vacuum to the implant.

FIG. 4 shows an alternative embodiment of a system 10′ constructedsimilar to the system 10 shown in FIGS. 1 and 2. The system 10′ shown inFIG. 4 includes an elongated member 20′ having a first inner lumen 22′and a second inner lumen 23. Preferably, both the first inner lumen 22′and the second inner lumen 23 extend along the entire length of theelongated member 20′. The first inner lumen 22′ preferably extends froma proximal portion 28′ of the elongated member 10′ to a first opening24′ in a distal end 26′ of the elongated member 10′. The second innerlumen 23 preferably extends from the proximal portion 28′ to a secondopening 25 in the distal end 26′.

The first and second lumens 22′ and 23 could have many different crosssectional shapes and sizes. As shown in FIG. 5A, the second lumen 23could have a substantially circular cross section and be positionedpartially within the first lumen 22′. Alternatively, as shown in FIG.5B, the second lumen 23 could have a generally flattened crosssectional, configuration.

Implants 30 are loaded in the first lumen 22′. To push the implants 30through both the first inner lumen 22′ and the first opening 24′, thefirst lumen 22′ is preferably pressurized with fluid. As shown in FIG.4, a first fluid source 50 is in fluid communication with the firstinner lumen 22′. The first fluid source 50 is preferably a syringe orother pumping device capable of being activated to deliver a fluid, suchas saline or air, to the first inner lumen 22′. When the fluid deliveredby the first source 50 increases the pressure in the first inner lumen22′, one or more of the implants 30 are forced through the first innerlumen 22′ and through the first opening 24′. If the ejecting fluid is aliquid and the implant 30 is formed of open cell foam, the implant 30preferably does not absorb an undue amount of the liquid.

In an alternative embodiment, not shown, a pushing member similar oridentical to the pushing member 40 shown in FIGS. 1 and 2 is used inplace of the first fluid source 50 to eject implants 30 from the opening24′. In another alternative embodiment, not shown, the elongated member20 shown in FIGS. 1 and 2 has its inner lumen 22 in fluid communicationwith a fluid source, such as the first fluid source 50, rather thanhaving the pushing member 40.

As shown in FIG. 4, the second inner lumen 23 is preferably in flowcommunication with a second fluid source 52 similar or identical to thefirst fluid source 50. The second fluid source 52 is configured todeliver fluid, such as saline, through both the second inner lumen 23and the second opening 25. As explained below, the fluid flowing fromthe second opening 25 is used to separate layers of body tissue when thedistal end 26′ is placed in the tissue. This separation of the layer ofbody tissue facilitates placement of the implants 30 between the tissuelayers.

Preferably, the fluid provided by the second source 52 includes aradiopaque additive, which is capable of being detected by conventionalradiographic imaging equipment. The use of the radiopaque additivepermits a physician to view the location of the tissue separationprovided by the fluid from the second source 52. In addition, thisadditive provides a visible radiographic background to allow for aphysician to determine whether the distal end of the elongated member10′ is properly located.

Methods of bulking tissue to treat GERD are discussed below withreference to FIGS. 1-4 and 6-10. Although the invention is described inconnection with the structure shown in these figures, and in connectionwith treating GERD, it should be understood that the invention in itsbroadest sense is not so limited.

Initially, the elongated member 10 shown in FIGS. 1 and 2 or theelongated member 10′ shown in FIG. 4 is introduced into the body of apatient until the distal end 26, 26′ of the elongated member 10, 10′ ispositioned at or near (for example, below) the gastro-esophagealjunction. To reduce trauma, the elongated member 10, 10′ is preferablypassed transorally through the esophagus until the distal end 26, 26′ isat or near the stomach. In a preferred practice of the invention, anendoscope, such as a gastro-intestinal endoscope having visual imagingcapability, is initially inserted transorally through the esophagus, andthe elongated member 10, 10′ is introduced through a working lumen ofthe endoscope. In order to facilitate insertion and positioning of theelongated member 10, 10′, the elongated member 10, 10′ is preferablypositioned while a physician uses imaging equipment, such asfluoroscopic, radiographic, ultrasonic, and/or visual imaging equipment.

After the elongated member 10, 10′ is inserted in the esophagus, thedistal end 26, 26′ of the elongated member 10, 10′ is positioned betweenlayers of body tissue at or near the gastro-esophageal junction. Whenthe distal end 26, 26′ includes a sharp tip, such as that shown in FIGS.1, 2, and 4, the distal end 26, 26′ is pierced through the layers ofbody tissue.

As shown schematically in FIGS. 6-10, the tissue at or near thegastro-esophageal junction J includes three primary layers—the mucosalayer A which forms the inner lining of the esophagus E and stomach S,the submucosa layer B which is the intermediate tissue layer, and themuscularis layer C which is the outermost layer. Preferably, the distalend 26, 26′ shown in FIGS. 1, 2, and 4 is positioned so that the opening24, 24′ is located between the mucosa layer and the outer surface of themuscularis layer.

To facilitate proper positioning of the distal end 26, 26′ between theappropriate tissue layers, fluid is preferably placed between the tissuelayers to form a pocket that separates the layers of tissue. Forexample, when the elongated member 10′ shown in FIG. 4 is used, thefluid for separating the tissue layers is delivered through the secondopening 25 by the second fluid source 52. When the elongated member 10shown in FIGS. 1 and 2 is used, a separate needle is inserted into thelayers of tissue at or near the gastro-esophageal junction, and theneedle is used to inject fluid, like that delivered by the second fluidsource 52, between the tissue layers to separate them. Because theelongated member 10′ shown in FIG. 4 includes the second inner lumen 23,a separate needle or other structure is not required to separate thetissue layers with fluid.

After optionally separating the tissue with fluid to position the distalend 26, 26′, one or more of the implants 30 are ejected from the distalend opening 24, 24′ by pushing the implants 30 through both the innerlumen 22, 22′ and the opening 24, 24′. As the implants 30 are pushedthrough the opening 24, 24′, they expand from their compressedconfiguration, as shown in FIG. 2, for example.

The way in which the implants 30 are pushed through the opening 24, 24′depends on the particular structural arrangement being used. When theelongated member 20′ shown in FIG. 4 is being used, the implants 30 arepushed through the opening 24′ by pressurizing the inner lumen 22′ withthe fluid from the first fluid source 50. When the elongated member 20shown in FIGS. 1 and 2 is being used, the implants 30 are pushed throughthe opening 24 by moving the pushing member 40 distally in the innerlumen 22 and/or by retracting the elongated member 20 proximally withrespect to the pushing member 40 while the pushing member 40 contactsone of the implants 30 in the inner lumen 22. Retracting the elongatedmember 20 is preferred in certain circumstances because the implants 30are placed in the body at a location previous occupied by the distal end26.

Preferably, the implants 30 are placed between the mucosa layer and themuscularis layer at or near the gastro-esophageal junction. The implants30 could be arranged in a uniform or random manner. Preferably, theimplants 30 are placed in the submucosa layer, however, the implants 30may also be positioned in at least a portion of the muscularis layer andeven the mucosa layer.

Preferably, more than one of the implants 30 is placed in the layers oftissue adjacent to or at the gastro-esophageal junction, although itcould be possible to place only a single implant 30 in the tissue. Theexact number of implants 30 depends on a number of factors including theexpanded size of the implants 30 and the amount of tissue bulking whichis required. Having a plurality of implants 30 loaded in the lumen 22,22′ limits the need to load more implants or introduce another implantinsertion device.

If the implants 30 include anchor members 32, such as those shown inFIG. 3, the anchor members 32 preferably limit migration of the implants32. When the implants include hook-shaped anchors, such as the anchors30A shown in FIG. 12, the anchor members of adjacent implants can beinterconnected to form groups of multiple implants having limitedmigration.

FIGS. 6-8 show an example of how the implants 30 are preferably placedat multiple locations in the submucosa layer B located between theesophagus E and stomach S and slightly below the gastro-esophagealjunction J. As shown in FIGS. 6-7, the implants 30 are placed so thatthe longitudinal axes of the implants 30 are in a plane substantiallyperpendicular to the longitudinal axis of the esophagus E. However,other configurations are possible. For example, FIGS. 9 and 10 show theimplants 30 placed in the tissue layers so that the axes of implants 30are substantially parallel to the axis of the esophagus E.

When the implants 30 are positioned, as shown in FIGS. 6-8, so that theaxes of the implants 30 are in a plane that is substantiallyperpendicular to the axis of the esophagus E, the elongated member 20,20′ is preferably curved or bent, for example, like the member 20A shownin FIG. 12, to facilitate placing the implants 30 in the tissue whilethe elongated member 20, 20′ extends along the esophagus E. For example,the elongated member 20, 20′ could have a bend or curve that positionsthe axis of the distal end portion of the elongated member 20, 20′ in aplane substantially perpendicular to the axis of the remaining portionof the elongated member 20, 20′

FIGS. 6 and 7 show the implants 30 suspended in fluid F used to separatethe layers of tissue. Preferably, the structure that was used tointroduce this fluid F, such as the second opening 25, second lumen 23,and second fluid source 52, is also used to remove the fluid F to securethe implants 30 in place between the tissue layers. Alternatively, thefluid F is absorbed into the body. FIG. 8 shows the placement of theimplants 30 after the fluid is removed or absorbed.

Preferably the implants 30 bulk the tissue at or near thegastro-esophageal junction so that the bulked tissue assists the loweresophageal sphincter to limit reverse flow of stomach contents into theesophagus. Depending on the amount of bulking required, the implants 30do not always needs to be located directly at the gastro-esophagealjunction. Because the implants 30 are preferably compressible andflexible, they allow for relatively normal digestion. If necessary,additional implants 30 could be placed in the tissue at a later time toincrease bulking, or the implants 30 could be removed from the tissue inan endoscopic mucosectomy procedure.

Although the implant according to the invention is preferably used tobulk tissue at or near the gastro-esophageal junction in a GERDtreatment procedure, the implant could be used to bulk many differenttypes body tissue in different types of procedures. For example, theimplant could be used to bulk tissue along the urinary tract in aurinary incontinence treatment.

It will be apparent to those skilled in the art that variousmodifications and variations can be made to the structure andmethodology of the present invention without departing from the scope orspirit of the invention. In view of the foregoing, it is intended thatthe present invention cover modifications and variations of thisinvention provided they fall within the scope of the following claimsand their equivalents.

1-40. (canceled)
 41. A method of treating a gastrointestinal tractcomprising: positioning a distal end of an elongated member proximate atissue site in the gastrointestinal tract; piercing a mucosal layerproximate the tissue site with the distal end of the elongated member,the elongated member including a elongated bulking device; and ejectingthe elongated bulking device from the elongated member into the mucosallayer such that a longitudinal axis of the elongated bulking device issubstantially orthogonal to a longitudinal axis of the gastrointestinaltract.
 42. The method of claim 41, wherein the elongated member includesa second elongated bulking device, the method further comprisingejecting the second bulking device into the mucosal layer.
 43. Themethod of claim 42, wherein the first and second bulking devices includea plurality of anchor members.
 44. The method of claim 43, wherein thefirst bulking device is configured to couple to the second bulkingdevice via the anchor members.
 45. The method of claim 41, wherein thebulking device is ejected from the elongated member with a push rod, andwherein the bulking device expands from a compressed configuration to anexpanded configuration after being ejected.
 46. The method of claim 41,wherein the tissue site is a gastroesophageal junction, and theelongated bulking device is substantially orthogonal to a longitudinalaxis of the esophagus.
 47. The method of claim 42, wherein the first andsecond bulking devices are located in series in the elongated memberprior to ejecting.
 48. A method of treating a gastrointestinal tractcomprising: positioning a distal end of an elongated member proximate atissue site in the gastrointestinal tract, the elongated memberincluding at least a first bulking device and a second bulking deviceeach having an elongated shape, the first bulking device defining afirst longitudinal axis and the second bulking device defining a secondlongitudinal axis; piercing tissue proximate the tissue site with thedistal end of the elongated member; inserting the first bulking devicein the tissue; and inserting the second bulking device in the tissuesuch that the first longitudinal axis is substantially parallel to thesecond longitudinal axis.
 49. The method of claim 48, wherein the tissuesite is a gastroesophageal junction, and the tissue is a submucosallayer, the first and second longitudinal axes being parallel to alongitudinal axis of the esophagus.
 50. The method of claim 48, whereinthe first and second bulking devices further include a plurality ofanchor members.
 51. The method of claim 50, wherein the first bulkingdevice is configured to couple to the second bulking device via theanchor members.
 52. The method of claim 48, wherein the first and secondbulking devices expand from a compressed configuration to an expandedconfiguration after being inserted.
 53. The method of claim 48, whereinthe tissue site is a gastroesophageal junction, and the tissue is asubmucosal layer.
 54. A method of treating a gastrointestinal tractcomprising: positioning a distal end of an elongated member proximate atissue site in the gastrointestinal tract, the elongated memberincluding at least a first bulking device and a second bulking device;piercing a mucosal layer proximate the tissue site with the distal endof the elongated member; inserting the first bulking device in thesubmucosal layer; and inserting the second bulking device in thesubmucosal layer such that the second bulking device interconnects withthe first bulking device.
 55. The method of claim 54, wherein the firstand second bulking devices further include a plurality of anchormembers, the interconnecting of the first and second bulking devicesoccurring via the anchor members.
 56. The method of claim 54, whereininserting the second bulking device includes inserting the secondbulking device such that a longitudinal axis of the second bulkingdevice is substantially parallel to a longitudinal axis of the firstbulking device.
 57. The method of claim 54, wherein the first and secondbulking devices are located in series in the elongated member prior tobeing inserted.
 58. The method of claim 54, wherein the tissue site is agastroesophageal junction and the first and second bulking devices areinserted such that a longitudinal axis of each bulking device issubstantially orthogonal to a longitudinal axis of the esophagus. 59.The method of claim 54, wherein each of the first and second bulkingdevices expands from a compressed configuration to an expandedconfiguration after being inserted.
 60. The method of claim 54, whereinthe tissue site is a gastroesophageal junction.